Diagnostic accuracy of a non-invasive spot-check hemoglobin meter, Masimo Rad-67® pulse CO-Oximeter®, in detection of anemia in antenatal care settings in Kenya.

IF 2.3 Q2 OBSTETRICS & GYNECOLOGY Frontiers in global women's health Pub Date : 2024-10-14 eCollection Date: 2024-01-01 DOI:10.3389/fgwh.2024.1427261
Angela Koech, Isaac Mwaniki, Joseph Mutunga, Moses Mukhanya, Emily Mwadime, Marvine Ochieng, Grace Mwashigadi, Hiten D Mistry, Rachel Craik, Peter von Dadelszen, Marleen Temmerman, Stanley Luchters, Geoffrey Omuse
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Abstract

Background: Point of care hemoglobin meters play key roles in increasing access to anemia screening in antenatal care especially in settings with limited access to laboratories. We aimed to determine the diagnostic accuracy of a non-invasive spot-check hemoglobin (SpHb) meter, Masimo Rad-67® Pulse CO-Oximeter®, in the diagnosis of anemia in pregnant women attending antenatal care clinics in Kilifi, Kenya.

Methods: This was a diagnostic accuracy study that retrospectively evaluated SpHb against a validated reference standard of laboratory assessed hemoglobin (Lab Hb) by a SYSMEX XN-330 automated hematology analyzer. The study was nested within a prospective pregnancy cohort study that recruited unselected pregnant women from antenatal care clinics in two public hospitals in Kilifi County, coastal Kenya. Records with both SpHb and Lab Hb were selected from pregnancy visits between May 2021 and December 2022. Linear regression and Bland-Altman analysis were performed to compare the two tests and diagnostic accuracy parameters obtained for the diagnosis of anemia.

Results: A total of 2,975 records (from 2,203 unique participants), with paired SpHb and Lab Hb were analyzed. Linear regression showed a significant but weak positive correlation, a proportional bias of 0.44 (95% CI 0.41-0.47) and a constant of 7.59 (95% CI 7.30-7.87, p < 0.001). The median bias was 1.70 g/dl, with limits of agreement of -0.80 to 4.20. SpHb tended to be higher than Lab Hb on the low hemoglobin range but lower than Lab Hb on the high hemoglobin range. The sensitivity of SpHb in detecting anemia was 18.66%. Prevalence, specificity, positive predictive value, and negative predictive values were 46.37%, 96.77%, 83.33%, and 57.92% respectively.

Conclusion: Overall, SpHb by Masimo Rad-67® Pulse CO-Oximeter® did not accurately identify pregnant women with anemia and many cases would be missed. We would not recommend its use in antenatal care settings.

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肯尼亚产前护理机构在检测贫血时使用无创抽查血红蛋白仪 Masimo Rad-67® pulse CO-Oximeter® 的诊断准确性。
背景:护理点血红蛋白仪在提高产前护理中贫血筛查的普及率方面发挥着关键作用,尤其是在实验室条件有限的情况下。我们的目的是确定 Masimo Rad-67® Pulse CO-Oximeter® 无创点检血红蛋白 (SpHb) 计在诊断肯尼亚基利菲产前护理诊所孕妇贫血方面的诊断准确性:这是一项诊断准确性研究,通过 SYSMEX XN-330 自动血液分析仪,对照实验室评估血红蛋白(Lab Hb)的有效参考标准,对 SpHb 进行了回顾性评估。该研究嵌套在一项前瞻性妊娠队列研究中,该研究从肯尼亚沿海基利菲县两家公立医院的产前检查诊所招募未经选择的孕妇。研究人员从 2021 年 5 月至 2022 年 12 月期间的孕妇就诊记录中选取了 SpHb 和 Lab Hb。通过线性回归和Bland-Altman分析,比较两种检测方法和诊断贫血的准确性参数:共分析了2,975条记录(来自2,203名参与者),其中SpHb和Lab Hb成对。线性回归显示出显著但微弱的正相关性,比例偏差为 0.44(95% CI 0.41-0.47),常数为 7.59(95% CI 7.30-7.87,p 结论:总体而言,MasRobot SpHb 和 Lab Hb 可用于贫血诊断:总体而言,Masimo Rad-67® Pulse CO-Oximeter® SpHb 不能准确识别贫血孕妇,许多病例会被漏诊。我们不建议在产前检查中使用该仪器。
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